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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K903910
Device Name LUBRICATING JELLY
Applicant
LAKE PHARMACEUTICAL, INC.
700 THIRTEENTH ST. N.W.
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact SAMIA N RODRIGUEZ
Correspondent
LAKE PHARMACEUTICAL, INC.
700 THIRTEENTH ST. N.W.
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact SAMIA N RODRIGUEZ
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received08/23/1990
Decision Date 10/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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